Oslif Breezhaler

Withdrawn

This medicine's authorisation has been withdrawn

indacaterol

Overview

On 30 October 2026, the European Commission withdrew the marketing authorisation for Oslif Breezhaler (indacaterol) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Oslif Breezhaler was granted marketing authorisation in the EU on 30 November 2009 for the treatment of chronic obstructive pulmonary disease (COPD). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014.

Oslif Breezhaler was a duplicate application of Onbrez Breezhaler, which is marketed in several EU countries. The withdrawal of Oslif Breezhaler is not expected to have any impact on patient access to treatment, as the corresponding reference product, Onbrez Breezhaler, remains authorised and available on the market.

Oslif Breezhaler : EPAR - Summary for the public

Product information

Oslif Breezhaler : EPAR - Product Information

Oslif Breezhaler : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Oslif Breezhaler
• Active substance:
  indacaterol maleate
• International non-proprietary name (INN) or common name:
  indacaterol
• Therapeutic area (MeSH):
  Pulmonary Disease, Chronic Obstructive
• Anatomical therapeutic chemical (ATC) code:
  R03AC18

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Authorisation details

• EMA product number:
  EMEA/H/C/001210
• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park; Merrion Road; Dublin 4; D04 A9N6; Ireland

• Marketing authorisation issued:
  29/11/2009
• Withdrawal of marketing authorisation:
  30/10/2026
• Revision:
  20

Assessment history

Changes since initial authorisation of medicine

Oslif Breezhaler : EPAR - Procedural steps taken and scientific information after authorisation

Oslif Breezhaler : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Oslif Breezhaler-H-C-PSUSA-00001730-201611 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/677604/2017

Oslif Breezhaler-H-C-PSUV-0022 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/CHMP/352667/2016

Oslif Breezhaler-H-C-1210-PSU-08 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Initial marketing authorisation documents

Oslif Breezhaler : EPAR - Public assessment report

CHMP summary of positive opinion for Oslif Breezhaler

Reference Number: EMEA/CHMP/592262/2009